Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.

Screws provided in the device package are 6 mm longer than intended.

Arthrex notified customers of the recall on about 10/01/2019, via "URGENT: REMOVAL NOTIFICATION" letter. Customers were informed that the Low Profile Screw, labeled as 4.5 x 20 mm, in their package measures 6 mm longer than intended. Customers were instructed to immediately discontinue use, sale, and distribution of affected screws and to acknowledge receipt of the recall notification. Direct customers were directed to contact Anthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex agencies were directed to contact Arthrex Field Logistics Services at [email protected] as soon as possible to arrange for return of affected products. An email also accompanied the recall letter and requested that customers return all affected product. Questions can be addressed to Arthrex Product Surveillance at 866-267-9138 or [email protected].